Frederic S Resnic, Arjun Majithia, Danica Marinac-Dabic, Susan Robbins, Henry Ssemaganda, Kathleen Hewitt, Angelo Ponirakis, Nilsa Loyo-Berrios, Issam Moussa, Joseph Drozda, Sharon-Lise Normand, Michael E Matheny
BACKGROUND: The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI). METHODS: We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry...
February 9, 2017: New England Journal of Medicine